Technical Documentation

Comprehensive technical documentation is essential for regulatory submissions and maintaining compliance throughout the product lifecycle. Our TechFile Factory service provides a streamlined solution for creating, reviewing, and maintaining your technical documentation, ensuring it meets the stringent requirements of global regulatory authorities such as the FDA and the EU MDR.

Our technical documentation services cover everything from initial file creation to periodic updates required by evolving regulatory standards. This includes detailed descriptions of your device’s intended use, risk management files, clinical evaluations, and manufacturing processes. We also help ensure that your documentation is always audit-ready, making it easier to respond to regulatory inquiries and inspections.

Whether preparing for an FDA submission, a CE mark application, or post-market surveillance audits, our technical documentation services help you stay compliant with regulatory standards while minimizing the administrative burden on your team. We ensure that your technical documentation is accurate, up-to-date, and ready for submission to authorities.

We also assist with the development and maintenance of clinical evaluation reports (CERs), post-market surveillance (PMS) reports, and periodic safety update reports (PSURs), all of which are crucial components of a compliant technical file. Our experts ensure that your documentation not only meets current regulatory requirements but also evolves to stay in line with any future regulatory updates.

As part of our TechFile Factory service, we continuously manage your documentation updates to ensure that changes in device design, manufacturing processes, or regulatory requirements are promptly reflected. This proactive approach minimizes the risk of non-compliance and ensures that your documentation remains relevant and ready for submission at any point in the product lifecycle.

In addition to ensuring compliance with the EU MDR, we also help manufacturers transition to the increasingly stringent EU IVDR for in vitro diagnostic devices. This includes assistance with technical documentation updates required for re-certification under these new regulations.

Our TechFile Factory services:

• Update of existing technical documentation including product-specific documentation to correct deviations and nonconformities. These include, among others:
  • Intended purpose and product description
  • Risk management file according to ISO 14971
  • Usability file according to IEC 62366-1 and 82304-1
  • Software documentation according to IEC 62304
  • Cybersecurity documentation according to IEC 81001-5-1
  • Plan and report for clinical evaluation or performance evaluation
  • Evaluation of biological safety according to ISO 10993-1
  • Plan and report on post-market surveillance

• Creation of (technical) documentation according to European requirements (EU MDR, EU IVDR), US FDA requirements (510(k) and PMA) and for other international target markets
• Review of technical documentation to identify deviations
• Creation of all modules of the Common Technical Document according to Directive 2001/83/EC and current guidelines
• Support preparation of responses to feedback from Notified Bodies and regulatory authorities
• Training at your location

Additional technical documentation services:

• Technical documentation (MDR/IVDR): Including post-market surveillance and compliance updates
• Premarket submission and notification: Including 510(k) notifications and PMA submissions
• Gap identification and assessment: Broader identification of documentation gaps and areas for improvement
• Remediation of identified documentation gaps and areas for improvement

Our technical documentation services not only help manufacturers maintain compliance but also ensure that documentation is comprehensive, clear, and easily accessible in case of audits or regulatory inspections. With our expertise, you can confidently navigate the complex and evolving regulatory landscape.

We have compiled a list of articles and training courses on the issue of technical documentation to help you and your colleagues.

Top 5 Technical Documentation Challenges for Medical Device Manufacturers and Their Solutions
Learn about the top technical documentation challenges identified through our extensive experience and how to overcome them. From addressing cybersecurity risks to streamlining clinical evaluations.

Why Rigorous Clinical Evaluations Matter: Strategies to Boost Safety and Compliance
Did you know that 40% of medical device submissions are delayed due to inadequate clinical evaluations? In the highly competitive medical device market, mastering clinical evaluations is not just a regulatory hurdle but a strategic imperative.